Healthy Skepticism Library item: 9765

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Goldenberg MM.
Medicare and the New Generic Drug Legislation
P and T 2004; 29:(2):89-94

Abstract:

The Hatch-Waxman Act started the ball rolling for the introduction of generic drugs to the market, but because of the many loopholes associated with it, name-brand companies were able to stall legally (and sometimes illegally) the placement of these generic drugs on the market. Because of the awareness among consumers and their sensitivity to drug prices and the differences between name brands and generics, political pressure was exerted and Congress subsequently responded. Although the response was slow, changes to the law finally appeared in 2003. It is hoped that there will be less confusion regarding product placements for name-brand and generic companies. The Gregg-Schumer legislation clarifies that the FDA has the authority to allow generic drugs to enter the market for the original use, with modified labeling that ensures that products are safe and effective for use but does not include any information that is protected by patent or market exclusivity. For example, if a name-brand company is marketing a drug approved to treat hypertension and conducts studies revealing that the drug can also be used to treat cancer, a generic company is entitled to market the product for hypertension but not for cancer. This legislation would also allow generic companies to countersue and possibly avoid delay in getting their products to market. It also would block other tactics, including using pay-offs to generic companies to keep cheaper products out of the market. Because generics often grab 80% of a branded drug’s sales within just a few months after introduction, however, consumers, especially senior citizens, will continue to experience problems related to the high R& D costs of prescription drugs.